TALLAHASSEE, Fla., May 18, 2018 /PRNewswire/ -- Prevacus, Inc., a leading biopharmaceutical company focused on developing treatments for concussion (mild traumatic brain injury (mTBI)) and other neurological disorders today announced a partnership with BrainScope for use of their FDA-cleared BrainScope One device in Prevacus' upcoming Phase 1b clinical research study as an objective biomarker of brain function. Prevacus and BrainScope are supported in their efforts to find a solution to concussions for youth and professional athletes by 3 Super Bowl MVP quarterbacks including Brett Favre, Kurt Warner and Mark Rypien.
Read full white paper here: BrainScope One Urgent Care ED Diversion White Paper – May 2018
The standard of care today for assessment of traumatic brain injury (TBI) in the Emergency Department (ED) remains the head CT scan, despite the fact that 91% of those scanned are reported to be negative for structural brain injury. Since approximately 95% of head injured patients present as mild, there are a very large number of unnecessary CT scans performed for the mTBI/concussion population. Urgent Care Centers (UCC) have the potential to significantly impact on initial triage and assessment of mild head injured patients, yet today standard clinical assessment capabilities in UCC result in a large percentage of such patients being referred to the ED for CT imaging, most often found to be negative. The ability to objectively assess these patients at the UCC could greatly improve evaluation and care of the mTBI/concussion population. BrainScope One is a novel handheld, rapid, easy to use, FDA cleared medical device to aid in the objective assessment of full spectrum of brain injury, including the likelihood of a structural brain injury visible on CT, with high accuracy shown in a prospective independent FDA validation trial. This White Paper evaluates the reduction of unnecessary UCC referrals to the ED for CTs when BrainScope One was integrated into the clinical decision pathway, based on 196 patients whose data was entered data into the BrainScope One Registry by 12 UCC. Significant reductions in ED referrals were realized (as high as 75%) when BrainScope One was used to aid in referral decisions across a wide range (100% to 50%) of prior clinical practice referral rates, supporting the potential to significantly impact on ED diversion and reduction of unnecessary CT scans in the mild brain injury population, benefiting the patient and reducing costs to the healthcare system.
BrainScope One Provides Objective, Actionable Information for Assessment of Mildly Presenting Head Injured Patients in Urgent Care Centers, Emergency Departments, and Other Settings
BETHESDA, MD. MAY 7, 2018 – BrainScope announced today the release of a white paper authored by Urgent Care physicians which demonstrated that the FDA-cleared BrainScope One had the potential to reduce unnecessary Emergency Department referrals by up to seventy-five percent. BrainScope One offers a rapid (within minutes) assessment of the full spectrum of traumatic brain injury (TBI), including concussion, using digital electroencephalography (EEG) and other modalities, facilitating accurate and timely decision-making for first responders, clinicians, and other health practitioners at the point of care wherever an injury occurs.
Close to 5 million people who experience a TBI seek care and treatment at hospital Emergency Departments (EDs) in the U.S. each year, where over 80% of these patients are evaluated using a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment. Over 90% of these CT scans are found to be negative, unnecessarily exposing patients to radiation, long wait times, and high costs.
BETHESDA, MD. APRIL 30, 2018 – BrainScope announced today the release of a white paper authored by physicians at Washington University Barnes Jewish Medical Center in St. Louis, which demonstrated that the FDA-cleared BrainScope One had the potential to reduce the use of unnecessary head CT scans by one-third in a hospital Emergency Department setting.
Today most patients seen in the emergency room with a suspected head injury receive a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, the vast majority of these patients do not have detectable intracranial lesions visible on the CT scan. The availability of BrainScope One can help health care professionals determine the need for a CT scan and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
Using data entered in BrainScope’s national Registry, the white paper authors compared 64 patients who were referred for CT scan…
Read full white paper here: Washington University Emergency Department White Paper
Despite the fact that most CT scans performed on head injured patients are negative, CT remains the “gold standard” for evaluation of head injury in the Emergency Department. This study investigates the utility of the BrainScope One EEG based classification algorithm to aid in the reduction of unnecessary CT scans in the mild head injured population. Evaluations were performed on 64 patients (mean age 43.5, 58% male, 98% GCS=15), enrolled in the BrainScope One Registry, who sustained closed head injury and were evaluated in the ED at Washington University (mean time since injury 10.1 hours) and were referred for CT scans by standard clinical site practice pathway. Results were compared with those from BrainScope One evaluation. In this population of ED patients, the BrainScope One decision pathway would have resulted in a 32.8% reduction in the overall number of CT scans referrals compared to the clinical site practice decision pathway. Importantly, this reduction in CTs was achieved without incurring any false negative cases (100% sensitivity).
By Alex DeMetrick
BALTIMORE (WJZ) — When it comes to looking for the first signs of concussion or other brain injuries, a new tool is available from a Maryland company — and it’s being backed by the NFL and the Department of Defense.
The device, called BrainScope, comes in two parts. It includes a disposable electrode headset, and a military-grade smartphone with specialized software.
The tool is designed to give an objective appraisal of possible brain injury as early as possible after an accident:
“So much of brain injury assessment is subjective, and so what we are adding is objectivity. You’re literally reading the brain electoral activity of the patient,” says Michael Singer, CEO of BrainScope.
“Close your eyes, relax and keep your feet flat on the floor.”
The software compares activities of an uninjured brain, like relaxing, with the readings of someone who suffered a concussion.
It also compares cognitive functions with tests taken by the patient, which could lead to a CT scan.
“We run multiple tests and that aggregation is what is then used by the clinicians for them to make a diagnosis,” says Singer.
Supporters of Bethesda-based BrainScope include the military, with the defense department providing funding, as well as the NFL, where brain injuries to players have gone from locker room secret to full-blown headlines:
“There’s just no denying a lot of guys out there like me dealing with the stage of brain injury,” says former NFL player Mitch White.
The portability of BrainScope means versatility with FDA approval.
“It’s meant to be anywhere a head injury might occur, so our markets are places like urgent care centers, emergency room departments in hospitals, the military, universities,” says Singer.
Startups attract funding to expand sales of tests, tools to detect and
manage brain injuries and illnesses
By Brian Gormley
Sept. 11, 2017 7:30 a.m. ET
Venture capitalists have money in the brain.
After years of research and development, many startups have introduced money-making products or services aimed at conditions of the brain, attracting more capital.
Brain startups with revenue closed 26 venture financing rounds in the first half of the year, on pace to pass the high reached in 2015 of 44 financing rounds for revenue-generating brain companies, according to Dow Jones VentureSource,
These private companies are gaining traction serving a range of conditions such as depression, anxiety and concussions.
The percentage of investments in those ringing up sales is rising. In 2008 the portion of brain investments in startups that were generating revenue was 13%. By 2012 that figure had risen to 40%. Last year, there were 38 financings in revenue-making startups in the brain category, or 42% of the total. In the first half it reached 50%.
BETHESDA, MD. September 7, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device, BrainScope One, for assessment of the full spectrum of traumatic brain injury, announced it will immediately commence development of a pediatric capability. The pediatric product will be similar to the currently-available BrainScope One, which is a handheld, easy-to-use, rapid, objective capability to aid the clinician in the assessment of mildly presenting adult head injured patients at the point of care. It is designed to help the clinician assess the full spectrum of brain injury, including whether a patient has structural brain injury likely visible on CT, as well as whether a patient has functional brain impairment, including concussion. BrainScope One measures and interprets the patient’s brain electrical activity and neurocognitive function, and offers a panel of objective data to help physicians make their clinical diagnosis.
BETHESDA, MD. August 30, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device for assessment of the full spectrum of traumatic brain injury, today announced it has completed a $16 million equity financing. New investor DBL Partners joined previous backers Revolution LLC, ZG Ventures, Maryland Venture Fund and other existing and new investors in the round, which the company will use to support the commercial launch of its flagship BrainScope One medical device, as well as for continued research and development initiatives.
“We are delighted to have closed this financing with such outstanding investors. This investment acknowledges our leadership position as the first and only handheld, objective, FDA-cleared medical device for traumatic brain injury assessment. The financing will not only help the company drive commercial sales within various markets, but will also provide capital for research and development to broaden our product portfolio,” stated Michael Singer, CEO of BrainScope.
NEW YORK, July 26, 2017 /PRNewswire/ -- The Galien Foundation announced today the 2017 11th Annual Prix Galien USAAward Nominees. Counted among the global health innovation industry's most prized honors, the Prix Galien Award recognizes outstanding biomedical and technology product achievement that improves the human condition.
To qualify, each candidate must be U.S. Food and Drug Administration (FDA) approved for market within the last five years and demonstrate tremendous potential to impact human health. Sales data are not considered by the nominating committee in their award nominee selection; only science and health impact.
BETHESDA, MD. July 10, 2017 – BrainScope Company, Inc. today announced that it has received the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market.
“A pioneer in quantitative TBI assessment, Brainscope is poised for rapid and expansive growth. Frost & Sullivan firmly believes that BrainScope is set to become the respected and recognized clinical standard for mild head injury assessment,” stated Patrick Riley, Principal Analyst at Frost & Sullivan. The full write up of the award can be found here.
Frost & Sullivan has 50 years of experience researching technical and economic trends and best practices to provide clients with a complete picture of their position within an industry. As part of this ongoing research, Frost & Sullivan identifies companies that have successfully introduced new and innovative products into their markets, with emphasis on product quality and customer value. This process involves extensive primary and secondary research across the entire value chain of specific products. The 2017 New Product Innovation Award for Product Innovation in the Traumatic Brain Injury Assessment Solutions Market compared top manufacturers in three key areas: understanding demand, nurturing the brand, and differentiating from the competition. BrainScope received top marks in all areas of the research.
“We are honored to be recognized by Frost & Sullivan, whose analysts closely track our industry. We greatly appreciate the recognition for our innovation in developing and introducing our FDA-cleared product, BrainScope One, which addresses the very significant need for objective and comprehensive brain injury assessment,” stated Michael Singer, CEO of BrainScope.
FDA-Cleared BrainScope One Provides Proprietary, Objective EEG-Based Biomarker for Brain Injury, Including Concussion
BETHESDA, MD. June 14, 2017 – BrainScope Company, Inc. today announced a publication describing that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.
Published online in the peer-reviewed Journal of Neurotrauma in an article entitled “A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial”, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients.
Over 1 Million CT Scans Could Be Eliminated Annually in the U.S. by Incorporating BrainScope One into Standard Clinical Practice
BETHESDA, MD. June 1, 2017 – BrainScope Company, Inc. today announced a publication describing the use of its flagship product, BrainScope One, in an independent clinical trial demonstrating the potential reduction of one-third (33.3%) of unnecessary computed tomography (CT) scans of mildly presenting head injured patients in hospital emergency rooms (ERs). The study entitled “Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker” was published online in the peer-reviewed American Journal of Emergency Medicine.
According to recent publications, approximately five million patients are seen in U.S. hospital ERs each year with closed head injuries, and millions more do not seek evaluation. The vast majority (>80%) of these patients receive a CT scan, of which over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients.
BETHESDA, MD. May 23, 2017 – BrainScope Company, Inc. today announced the results of a study spanning over six years demonstrating that sports-related concussions can be objectively assessed using BrainScope’s proprietary electroencephalography (EEG) based Brain Function Index (BFI). Published in the peer-reviewed Journal of Head Trauma Rehabilitation, the study entitled “The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes” was conducted at 14 colleges and high schools, and funded in part through an award received under the NFL-GE Head Health Challenge I. In the study, 354 male contact sports athletes, 110 of whom sustained a concussion, were evaluated with results demonstrating that concussive injury significantly affected brain function, which was reflected in the BFI of the concussed athletes.
BrainScope’s BFI, derived from characteristics of brain electrical activity that most closely reflect the physiology of concussion, was found to show highly significant differences between concussed athletes at the time of injury compared with non-injured athletes. Furthermore, at both pre-season baseline and 45 days following the injury, concussed athletes and the non-injured control group exhibited equivalent BFI scores, suggesting that the BFI can potentially provide an objective marker of concussive injury and recovery over time.
The Centers for Disease Control and Prevention estimates that there are up to 3.8 million sports and recreation related concussions in the United States each year. Further, a 2014 JAMA publication reported head injury related hospital emergency room (ER) visits have increased...
BrainScope to Showcase New-to-Market Medical Technology at
Momentum 2017: UCAOA Urgent Care Convention and Expo
Bethesda, MD – BrainScope Company, Inc. today announced it will unveil its new FDA-cleared, objective comprehensive head injury assessment device, BrainScope One, at Momentum 2017: UCAOA Urgent Care Convention and Expo from April 30 to May 3 at the Gaylord Resort and Convention Center in National Harbor, Maryland.
BrainScope One is a revolutionary medical technology that gives urgent care physicians and staff greater assurance to objectively assess the full spectrum of brain injury, including concussion. This handheld, easy-to-use product was recently rebranded by the company from the Ahead 300 to BrainScope One.
Peer-Reviewed Publication Demonstrates BrainScope’s Ahead 300 Significantly Improves Prediction of TBI Beyond Standard Clinical Risk Factors Used Today
BETHESDA, MD. February 27, 2017 – BrainScope Company, Inc. today announced a publication demonstrating that prediction of a CT positive traumatic brain injury (TBI) is significantly improved when the electroencephalography (EEG) based biomarker from its Ahead 300 is used in addition to the most commonly considered predictive risk factor, Loss of Consciousness (LOC). The results of this study entitled “Increased prognostic accuracy of TBI when a brain electrical activity biomarker is added to Loss of Consciousness (LOC),” were published in the peer-reviewed American Journal of Emergency Medicine. Results of this study show an 83% improvement in the prediction of TBI using the Ahead 300 compared to that obtained using a history of LOC alone or LOC plus traumatic amnesia, the two most commonly used clinical diagnostic indicators for TBI.
Likelihood of CT+ vs. CT- Is One Component of the Ahead 300’s Configurable Panel of Capabilities for Mild Head Injury Assessment
BETHESDA, MD. February 16, 2017 – BrainScope Company, Inc. today announced a publication describing an independent clinical trial of 720 patients conducted in 11 U.S. Emergency Departments (EDs), validating the clinical efficacy of its Ahead 300 technology for the identification of Traumatic Brain Injury (TBI) in mildly presenting head injured patients. The results of this validation trial, “Emergency Department triage of traumatic head injury using brain electrical activity biomarkers: a multisite prospective observational validation trial” are published online in the peer-reviewed journal Academic Emergency Medicine.
In 2013, GE and the NFL teamed up to launch the GE-NFL Head Health Initiative, a four-year, $60 million collaboration to accelerate diagnosis and improve treatment for traumatic brain injury.
The initiative’s three-part Head Health Challenge open innovation program allocated $20 million for awarding grants to scientists, academics, entrepreneurs and other experts with leading ideas.
BrainScope used support from the Head Health Challenge to develop a new hand-held device that also has the potential to transform front-line care of head injuries.
BrainScope’s Ahead 300 headset and smartphone uses “sophisticated algorithms” to analyze patients with head injuries. It’s a quick test that is intended to provide “a rapid, objective assessment of the likelihood of the presence of traumatic brain injury (TBI) in patients who present with mild symptoms at the point of care.”
It was built in part through grant support from the GE-NFL Head Health Challenge. The U.S. Department of Defense also collaborated on the project.
In September 2016, the U.S. Food and Drug Administration gave the green light to BrainScope to begin marketing the Ahead 300.
Source: NFL Play Smart Play Safe (Click here to see NFL video with BrainScope)
Ahead 300 Offers Objective, Configurable Panel of Capabilities at the Point of Care
Company's First Commercial Product to Ship in Q1
BETHESDA, MD January 5, 2017 – BrainScope Company, Inc. announced today the market release of its flagship Ahead 300 product, and will initiate a limited launch to a select group of thought leadersthrough its Centers of Excellence program later in the first quarter. These institutions will represent a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, Emergency Medicine Departments, and University and Professional Sports. BrainScope will also be selling the Ahead 300 to various branches of the U.S. military and government.
DISCLAIMER: The Ahead 300 is intended to be used in Emergency Departments, Urgent Care Centers, Clinics and other environments where trained medical professionals and practitioners practice medicine under the direction of a physician.